EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System— 510(k) K233788
Substantially EquivalentPhilips Ultrasound, LLC
FDA 510(k) clearance K233788 for EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System, Substantially Equivalent on 2024-02-13. Applicant: Philips Ultrasound, LLC.
Clearance details
- Applicant
- Philips Ultrasound, LLC
- Product code
- Code IYN
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bothell, WA, US
Adverse events under product code IYN
product code IYN- Death
- 25
- Injury
- 163
- Malfunction
- 1,538
- Other
- 4
- Total
- 1,730
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.